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Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
toxicity to reproduction
Remarks:
other: subacute study
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD TG 407
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: PEG 400
Details on mating procedure:
not applicable because it is a subacute study
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
29 days
Frequency of treatment:
once daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 100, 300, 1000 mg/kg bw and day
Basis:
actual ingested
No. of animals per sex per dose:
5
Control animals:
yes, concurrent vehicle

Results and discussion

Results: P0 (first parental animals)

Effect levels (P0)

Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (actual dose received)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects on reproductive organs or tissues seen after oral dosing for 28 days
Remarks on result:
other: Generation not specified (migrated information)

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No adverse effects on reproductive organs or tissues were observed in a subacute oral study with rats up to and including 1000 mg/kg and bw.
Executive summary:

In a repeated dose toxicity study in rats (Wistar, OECD TG 407) the substance was administered via gavage to 5 rats/sex/dose at 0, 100, 300, 1000 mg/kg bw in PEG 400 for 4 weeks. Up to and including the limit dose of 1000 mg/kg bw neither gross pathological nor histopathological changes of the male and female reproductive organs (testes, epididymides, prostate, seminal vesicles incl. coagulation glands, ovaries with oviducts, uterus with cervix, vagina, mammary glands) were reported. Overall, based on the subacute toxicity study there is no indication of a reproductive toxicity potential of Desmorapid 01 and the NOAELfor reproductive effects for male and female rats can be considered as 1000 mg/kg bw.